The U.S. Food and Drug Administration (FDA) has, jointly with the U.S. Federal Trade Commission (FTC), issued a warning letter to Lattice Biologics, Ltd., for marketing an unapproved amniotic fluid product, sometimes referred to as AmnioBoost. The company claims AmnioBoost can mitigate, prevent, treat, diagnose or cure Severe Acute Respiratory Syndrome (SARS) or Acute Respiratory Distress Syndrome (ARDS) related to COVID-19.
The warning was issued after the FDA and FTC reviewed the company’s website and social media presence. Based on that review, the FDA and FTC determined this product is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
The product is also a biological product under section 351 of the Public Health Service Act (PHS Act), 42 U.S.C. § 262. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. 42 U.S.C. § 262(a). Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 C.F.R. 601.21; 21 C.F.R. Part 312. The company’s amniotic fluid product is not the subject of an approved BLA nor is there an IND in effect for the product.